The Consumer Justice Foundation Alerts the Public of New FDA-Mandated Warning Language on Containers of Topamax Regarding Potential Topamax Side Effect Glaucoma

Share Article

The Consumer Justice Foundation, a for-profit corporation that is staffed by a team of professional consumer advocates whose mission is to provide information to consumers regarding the potential dangers of prescription medications, hereby alerts the public to be aware of the new warning language on containers of Topamax that warn of the Topamax side effect glaucoma. The CJF’s Web site can be found at http://www.consumerjusticefoundation.com.

"Alternative medications that have a lower risk of birth defects should be considered."

The Consumer Justice Foundation, a for-profit corporation whose mission is to have its professional consumer advocates warn consumers of the dangers of certain prescription medications, hereby alert the public of the new warning language that is beginning to appear on the containers of Topamax that warn specifically of the risks of patients developing the Topamax side effect of glaucoma. This language will appear on labels of the medication and should be read carefully by consumers before using this medication.

Specifically, the FDA in March of this year ordered Johnson & Johnson, the manufacturer of Topamax, to include warning language on the labels of this medication, and this language that appears on the label that warns of the potential for developing the Topamax side effect known as glaucoma appears as follows on these labels:

"A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating TOPAMAX therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful".

This warning language appears on the literature that's associated with Topamax that's issued by Johnson & Johnson, and it also appears under the "5 WARNINGS AND PRECAUTIONS
5.1 Acute Myopia and Secondary Angle Closure Glaucoma" heading on the Topamax.com Web site. "Alternative medications that have a lower risk of birth defects should be considered," said Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

Topamax was originally approved by the FDA in 1996, and it is used to treat seizure disorders that include epilepsy. Since that time, other Topamax side effects have been allegedly linked to the use of this medication, including the risk of mothers who use this medication during the first trimester of pregnancy to have children with genital birth defects.

About the Consumer Justice Foundation

The Consumer Justice Foundation, whose Web site can be found at http://www.topamaxbirthinjury.com, is a for-profit organization that serves two purposes for consumers: (1) to provide educational information regarding the policies and procedures of large corporations and how they affect the average consumer; and (2) to provide news updates and resources that continue to update consumers regarding developments taken by corporations that include pharmaceutical drug companies, auto manufacturers and insurance companies so that consumers who have been harmed can use these informational resources to connect to an experienced professional who can help them. The team at the Consumer Justice Foundation is staffed by experienced and passionate consumer advocates whose mission is to raise the awareness of issues that could pose a risk of harm to those who may not otherwise be aware of the dangers they face.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Faith Anderson